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Abstral FDA Approval History

Last updated by Judith Stewart, BPharm on June 9, 2020.

FDA Approved: Yes (Discontinued) (First approved January 7, 2011)
Brand name: Abstral
Generic name: fentanyl
Dosage form: Sublingual Tablets
Company: Orexo AB
Treatment for: Pain

Marketing Status: Discontinued

Abstral (fentanyl) is a sublingual opioid analgesic indicated for the management of breakthrough pain in cancer patients.

Development timeline for Abstral

Jan 10, 2011Approval FDA Approval for Abstral (Fentanyl) Sublingual Tablets
Sep  7, 2010Update on the FDA review for Abstral
Jun 15, 2010Orexo confirms Abstral PDUFA date update
Oct  6, 2009Orexo confirms FDA acceptance of Abstral filing
Aug  6, 2009Abstral NDA submitted to the FDA for approval in the USA

Further information

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